The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.

This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.

Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.

• Androgen Independent Prostate Cancer (AIPC)
• Non Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

• Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
• Able and willing to give written informed consent

Exclusion Criteria:

• Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
• Prior investigational therapy other than DN-101 within 30 days of enrollment
• Known hypersensitivity to calcitriol
• Pregnancy (women of childbearing potential only)
• Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies